Historically the purpose of dental floss was: (1) to dislodge and remove decomposing food material that accumulated at interproximal and subgingival surfaces and could not be removed by brushing or rinsing, and (2) to dislodge and remove bacteria, plaque and/or calculus that accumulated since the previous flossing and/or cleaning.
The concept of the use of dental floss for cleansing interproximal spaces appears to have been introduced by Parmly in 1819. Parmly suggested the use of waxed silk to clean teeth of persons subject to gingival inflammation.
The role of plaque, now described as subgingival biofilm, in gum disease is well documented. The need to physically remove subgingival biofilms routinely has become an accepted treatment for gum disease. Mechanical removal of subgingival biofilms can be achieved professionally through: scaling, planing, prophylaxis and polishing, and individually by tooth brushing, proxy brushing and flossing.
While these methods of physically removing subgingival biofilms from tooth surfaces are effective and well accepted; gum disease continues to be prevalent in the adult population, and consequently, improved means for the individual to physically remove subgingival biofilms routinely are indicated.
Furthermore, the spacing between teeth is not uniform and it varies considerably, not only from one place to another between the same pair of teeth, but also from one pair of teeth to another pair of teeth. The spacing varies in the same individual, among different individuals, and especially in the case of twisted teeth and teeth that have fillings, crowns, etc.
To accommodate tight spacing and those interproximal contacts that do not allow multifilament dental floss to be worked between teeth without fraying, breaking, etc., a vast array of “TEFLON” dental flosses have been commercialized. These shred-resistant, monofilament tapes are described in detail in the following U.S. patents, which are hereby incorporated by reference: U.S. Pat. Nos. 3,664,915; 3,953,566; 3,962,153; 4,096,227; 4,187,390; 4,256,806; 4,385,093; 4,478,665; 4,776,358; 5,033,488; 5,209,251; 5,220,932; 5,518,012; 5,718,251; 5,765,576; and 5,911,228.
The TEFLON-type tapes available commercially in the marketplace today, include: Gore's GLIDE® dental tape, Oral-B's SATIN FLOSS® dental tape, Johnson & Johnson's EASY FLOSS® dental tape, and Colgate's TOTAL® dental tape. All of these tapes can be worked between tight spaces with a minimum of fraying and breaking. Yet, unlike their multifilament counterparts such as Johnson & Johnson's woven floss, REACH® Gentle Gum Care, during flossing, these tapes do not release substantial quantities of cleaners, abrasives, tartar control ingredients, whiteners and active ingredients such as fluoride, antimicrobials, antibiotics, etc. The net of this shortcoming in failing to deliver substantial quantities of ingredients to those sites being flossed is that the tapes are generally perceived as most convenient in fitting between teeth, but unfortunately, they are generally perceived as: “not cleaning”, “not working”, “not doing much”, etc., once they are positioned between teeth.
When substantial quantities of cleaning, conditioning and treating substances are coated onto tapes, the resultant tapes are characterized by excessive flaking and breaking off of these coatings during processing, dispensing and wrapping of tape around the fingers. As a result, there are no commercial tapes available with substantial coatings of releasable ingredients suitable for working into and physically removing biofilms from interproximal and subgingival spaces.
Biofilms are notorious throughout nature for being difficult to remove. Working a monofilament tape over biofilms in the absence of substantial quantities of cleaners, abrasives, etc., is not effective in physically removing and/or disrupting substantial quantities of biofilms. The net is, critical biofilm buildup interproximally and subgingivally cannot be effectively physically removed with routine flossing with current commercial dental tapes, both PTFE tapes and bicomponent tapes.
Monofilament interproximal devices are described and claimed in: U.S. Pat. Nos. Re 35,439; 3,800,812; 4,974,615; 5,760,117; 5,433,226; 5,479,952; 5,503,842; 5,755,243; 5,845,652; 5,884,639; 5,918,609; 5,962,572; 5,998,431; 6,003,525; 6,083,208; 6,148,830; 6,161,555; and 6,027,592, the disclosures of which are hereby incorporated herein by reference. These dental tapes generally have serious shortcomings in gentleness, in delivering coatings during flossing and in being handled easily and conveniently during flossing
Polytetrafluoroethylene (PTFE) based interproximal devices are described in: U.S. Pat. Nos. 5,209,251; 5,033,488; 5,518,012; 5,911,228; 5,220,932; 4,776,358; 5,718,251; 5,848,600; 5,787,758; and 5,765,576. To date, no commercial versions of these tapes have been coated effectively and cannot be used to deliver active ingredients, interproximally and subgingivally during flossing. Handling during flossing is difficult. Most have to provide a consumer acceptable edge. Many are plagued with serious dimensional inconsistency problems, as well.
Several Patent Applications have been filed on monofilament dental tapes with coatings comprising from between about 20% by weight and about 120% by weight of the monofilament tape. These are described in U.S. Provisional Patent Application Ser. Nos. 60/227,433 and 60/227,255, filed 23 Aug. 2000 and Ser. No. 60/263,220, filed 22 Jan. 2001, all of which are hereby incorporated by reference.
There is clearly a need for a commercial, shred-resistant tape that is coated with releasable ingredients that help disrupt and/or physically remove biofilms from critical interproximal and subgingival sites when used regularly, and deliver chemotherapeutic agents as required in a site-specific manner.